The Efficacy of Oral Steroids in the Treatment of Acute Sciatica

Summary

Sciatica (lumbosacral radiculopathy) is a common diagnosis in primary care, occurring in
approximately one percent of all patients with acute low back pain. (1, 2) Traditional
treatment generally involves pain control (acetominophen, NSAID’s, or narcotics), activity
as tolerated, and time. (1, 3-8 ) The general consensus is that fifty percent of patients
with sciatica recover within six weeks, and that ninety percent are better in twelve
weeks.(4, 8) Those patients with intractable pain or progressive neurologic symptoms usually
receive epidural steroid injections and, if necessary, decompressive laminectomy or
discectomy. (2, 8, 9)

Low back pain and sciatica result in tremendous losses to our society in terms of decreased
productivity and cost of treatment. (1, 12) Oral steroids are inexpensive and relatively
safe medications that, if effective in reducing the pain and disability associated with
sciatica, could improve the quality of patients’ lives, and result in significant cost
savings to society at large. We hypothesize that the use of oral steroids to treat acute
sciatica will speed patients’ recovery as measured by: changes in physical findings, rates
of return to work and activities of daily living, pain and disability assessment scores, and
decreases in the use of narcotic and non-steroidal anti-inflammatory drugs (NSAID’s), and in
the need for epidural injection or surgical intervention.

Description

Inclusion Criteria

To be included in this study patients had to have a diagnosis of acute sciatica as
determined by the principle investigator based on the following criteria: unilateral leg
pain extending below the knee (with or without strength, sensory, or reflex changes), and a
positive straight leg raising sign (defined as as pain radiating from the buttock to below
the knee with elevation of the leg between zero and sixty degrees). Patients had to be
between twenty and sixty years of age, and had to be entered in [recruited into] the study
within one week of the onset of their symptoms.

Exclusion Criteria

Patients were excluded from the study if they were pregnant or had a history of diabetes,
renal failure, upper gastro-intestinal bleed, or major psychiatric disease. Patients also
had to be free of symptoms suggesting more serious underlying disease as defined by the
United States Agency for Healthcare Policy Research document: “Acute Low Back Problems In
Adults”. (11) “Red Flag” symptoms” included: a history of cancer, unexplained weight loss,
fever or chills, night sweats, a history of intravenous drug use, saddle anesthesia, bowel
or bladder incontinence, bone pathology, or a Neurologic emergency. Additionally, patients
could be excluded for any condition that the principle investigator thought might jeopardize
their safety.

Randomization and Blinding

Once the diagnosis of acute sciatica had been confirmed, subjects were randomized to
receive either a nine day tapering course of prednisone or placebo capsules. The principle
investigator and research nurse were blinded as to group assignment. All subjects received
current standard therapy for sciatica, including: a NSAID (ibuprofen, naproxen, etodolac, or
nambumetone), narcotics if needed (hydrocodone, propoxyphene, oxycodone, or morphine),
activity as tolerated, and a referral for physical therapy.

Study Design

Upon entering the study all patients underwent physical exam with attention to: straight leg
raising test (positive or negative), contralateral straight leg raising (positive or
negative), knee and ankle stretch reflexes (0-3+), foot sensation (normal or decreased),
strength (0-5) of quadriceps, foot dorsiflexors, foot plantar flexors, and ability to
perform five heel lifts (0-5). Patients also completed three written instruments: a “12 Item
Health Status Questionnaire” (13), a “Roland-Morris Disability Questionnaire” (14), and a
“Roland-Morris Pain Rating Scale” (14). Also noted at the intake visit and each subsequent
visit were the number of hours each patient was working or, if they were not employed or
were retired, their estimated percent of daily living activities they were able to
accomplish. Lastly, note was made of whether the patient had undergone epidural steroid
injection or surgical intervention since the previous visit. Each patient underwent the same
exam and completed the same questionnaires weekly for four weeks post recruitment, and then
monthly for five months. This led to a total of 6 months of follow-up.

All patients received non-steroidal anti-inflammatory medication and narcotic medication if
needed for pain control. Patients randomized to the study group received tapering course of
prednisone: 60 mg for three days, 40 mg for three days, and 20 mg for three days. Patients
randomized to the control (placebo) group received capsules identical in appearance to the
prednisone capsules but containing an inert filler substance. Patients were questioned at
each visit to determine whether they were taking their study medication (first nine days of
the study) and whether they were still taking non-steroidal or narcotic medication (entire
study).

Patients were encouraged to begin non-weight-bearing aerobic activities such as swimming
and/or bike riding as soon as their pain had subsided to a reasonable degree. At this point,
patients generally also referred to see a physical therapist.

Patients who had rapid improvement and were under fifty generally did not have any imaging
studies performed. Project staff ordered plain films of the lumbosacral spine for most
patients over age 50 . Irrespective of age, patients who had intractable pain or progressive
neurologic symptoms generally had plain films of the lumbosacral spine done and also
underwent magnetic resonance imaging (MRI). A separate analysis of pain level ratings,
narcotic and NSAID use, and return to work rates, was performed for this subgroup with the
thought that they probably represented patients with the most severe nerve root inflammation
and that the effects of oral prednisone might be more or less obvious in this group.

Statistical power analysis

Statistical power analysis was performed with the primary outcome of return to work within
14 days of the intervention. The proportion of the control group returning to work was
hypothesized to be 50%. Oral prednisone was hypothesized to have a 50% treatment effect,
resulting in a 75% rate of return to work within 14 days. Using chi square with continuity
correction, statistical power analysis found that a (study and control group) sample size of
80 per subgroup would have a power of 88% to find this difference (i.e., between 50% and
75%)statistically significant at p

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Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most frequently prescribed drugs for the treatment of sciatica. A previous Cochrane review on the efficacy of NSAIDs summarised findings fo...

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Sciatica or the sciatic syndrome is a common and often disabling low back disorder in the working-age population. It has a relatively high heritability but poorly understood molecular mechanisms. The ...

Medical and Biotech [MESH] Definitions

Sciatica

A condition characterized by pain radiating from the back into the buttock and posterior/lateral aspects of the leg. Sciatica may be a manifestation of SCIATIC NEUROPATHY; RADICULOPATHY (involving the SPINAL NERVE ROOTS; L4, L5, S1, or S2, often associated with INTERVERTEBRAL DISK DISPLACEMENT); or lesions of the CAUDA EQUINA.

Oral Medicine

A branch of dentistry dealing with diseases of the oral and paraoral structures and the oral management of systemic diseases. (Hall, What is Oral Medicine, Anyway? Clinical Update: National Naval Dental Center, March 1991, p7-8)

Prednisone

A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.

Procarbazine

An antineoplastic agent used primarily in combination with mechlorethamine, vincristine, and prednisone (the MOPP protocol) in the treatment of Hodgkin's disease.

Oral Hygiene

The practice of personal hygiene of the mouth. It includes the maintenance of oral cleanliness, tissue tone, and general preservation of oral health.

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